Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Brinzolamide 10mg/ml &
Brimonidine tartrate 2 mg/ml
eye drops suspension by AZAD Pharma AG: Each study patient will self-administer one drop of test or reference product in the study ey
Sponsors
AZAD Pharma AG
Veeda Clinical Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients, aged 18-75 years (both inclusive), diagnosed with bilateral or unilateral open-angle glaucoma or ocular hypertension, who in the opinion of the Investigator, were insufficiently controlled on monotherapy or were already on multiple IOP lowering medications. 2. Mean IOP measurements in at least one eye (the same eye), must have been: ? = 24 mmHg and = 36 mmHg at the 9 a.m. time point, and ? = 21 mmHg and = 36 mmHg at the 11 a.m. time point at both the Eligibility 1 and Eligibility 2 visits following washout of any IOP-lowering medication. ? Mean IOP must not have been > 36 mmHg in either eye at any time point. 3. Adequate wash-out period prior to baseline of any ocular hypotensive medication. 4. Patients must have provided IEC approved written informed consent using the latest version of the IEC informed consent form. 5. Patients must be in good health and free from any clinically significant disease apart from indication under study. 6. Patients able to comply with study procedures in the opinion of the investigator. 7. Study patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits. 8. Patients must be able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period. 9. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration).
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females. 2. Chronic, recurrent or severe inflammatory eye disease. 3. Severe central visual field loss (i.e., sensitivity =10 dB in =2 of the 4 visual field test points closest to the point of fixation) in either eye. 4. Schaffer angle grade 5. Cup-to-disc ratio >0.80 (horizontal or vertical measurement) in either eye. 6. Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent). 7. Unable to safely discontinue IOP-lowering ocular medications per the washout schedule. 8. Current or history within 3 months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, ocular inflammation, corneal ulcerin either eye or corneal foreign body. 9. Ocular trauma within the preceding 6 months. 10. Contraindication to brimonidine tartrate, brinzolamide or sulfonamide therapy or known hypersensitivity to sulfonides or any component of brimonidine tartrate and brinzolamide ophthalmic suspension. 11. Use of intraocular corticosteroid implant at any time prior to baseline. 12. Use of contact lens within one week prior to baseline. 13. Ocular laser surgery within the 3 months prior to entry. 14. Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid. 15. Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose (more than 1 g daily) salicylate therapy 3) monoamine oxidase(MAO) inhibitor therapy, 4) any antidepressant which affects noradrenergic transmission (e.g. tricyclic antidepressants, mianserin) or 5) adrenergic–augmenting psychotropic drug (e.g. desipramine, amitriptyline). 16. Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid. 17. Underwent within six months prior to baseline any other intraocular surgery (e.g., cataract surgery). 18. Underwent within 12 months prior to baseline: refractive surgery, filtering surgery for IOP reduction. 19. Amblyopia - only one sighted eye. 20. Clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye. 21. Any abnormality preventing reliable applanation tonometry. 22. History or presence of significant alcoholism or drug abuse in the past one year. 23. Active smoker at the time of screening. 24. Active or prior severe, unstable, or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease that would prevent safe administration of topical a-adrenergic agonists or carbonic anhydrase inhibitors, according to the investigator. 25. Any form of glaucoma other than open-angle glaucoma. 26. Therapy with an investigational agent within the past 30 days from screening. 27. Clinically significant hematologic and/or biochemical abnormalities based on laboratory testing as judged by investigator. 28. Patients who are at risk of visual field or visual acuity worsen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is mean change from baseline to week 12 in diurnal IOP [the average of the IOP measured at 9 a.m. and 11 a.m. time points] of study eye in the test arm as compared to reference arm. Timepoint: • Screening • Visit 2 – Eligibility Visit (At the end of the washout period for patients who already had received IOP lowering medications) • Visit 3 (3-8 days after eligibility (Visit 2)) • Visit4 –Follow up Visit(week 2) • Visit5 –Follow up Visit(week 6) • Visit6 –End of study(week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability profile of the test product and reference product.Timepoint: • Mean change from baseline to Week 2 and Week 6 in diurnal IOP [the average of the IOP measured at 9 a.m. & 11 a.m-assessment time points] of study eye in the test arm as compared to reference arm using ANCOVA. • Mean change from baseline to Week 2, 6 & Week 12 in IOP & IOP percent for each assessment time point. • Ocular tolerance – The difference between the test & reference products with respect to ocular comfort level score and conjunctival hyperemia at baseline-Day 1 and Week 12. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Ltd
Outcome results
None listed